Label: GLACIERIX- capsaicin-menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69691-150-15 - Packager: Pharmaco Technology LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 23, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL
- WARNINGS AND PRECAUTIONS
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
GLACIERIX
capsaicin-menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69691-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin .0375 g in 100 g menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 5 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) propylparaben (UNII: Z8IX2SC1OH) aloe vera leaf (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) methylparaben (UNII: A2I8C7HI9T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) polysorbate 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69691-150-15 100 g in 1 BOX; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 04/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2015 Labeler - Pharmaco Technology LLC (079722491)
